Organ transport apparatus with sample compartments

ABSTRACT

An apparatus for at least one of storage, treatment, assessment and transport of an organ or tissue includes a cooling container configured to cool the organ or tissue, a perfusion circuit configured to perfuse the organ or tissue, and a sample compartment for holding a biological sample. Preferred apparatus has a first internal compartment under a first cover (lid) of the apparatus that includes the coolant container and the sample compartment. The apparatus can include a second internal compartment under a second cover (lid) of the apparatus, the second internal compartment including at least part of the perfusion circuit and a sample compartment.

CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional application of U.S. application Ser.No. 13/545,210, filed Jul. 10, 2012, the contents of which areincorporated herein by reference.

BACKGROUND

Biological samples may be used for a variety of reasons in conjunctionwith an associated organ or tissue that is being stored, transported,assessed and/or treated in a perfusion apparatus. Typically, biologicalsamples are transported at the same time as the organ or tissue but thesamples and the organ or tissue are not cooled simultaneously at thesame temperature within a single apparatus. Documents such as medicalrecords relating to each of the biological samples and the organ ortissue are typically transported in separate devices.

The practice of storing or transporting organs or tissue, biologicalsamples and documents associated with the organs or tissues may suffercertain shortfalls. When biological samples and documents relating to anorgan or tissue are separately stored and/or transported from the organor tissue, the likelihood that they may be misplaced, misassociatedand/or damaged is increased. If documents for the organ or tissue arelost or cannot be correlated with the organ or tissue with certainty,then a doctor or clinician may refuse to transplant the organ or tissueto a recipient or otherwise use the organ or tissue. If the documentsare lost or cannot be correlated to the organ or tissue or biologicalsample, results from any testing or use of the biological samples, organor tissue may be invalid or disregarded.

The practice of storing or transporting biological samples with an organor tissue also suffers certain deficiencies. Some biological samplesneed to be handled to maintain viability in a similar manner as an organor tissue. For example, sterility and temperature requirements may berequired for the organ or tissue and the biological samples. Thus, anefficient and more effective means of cooling a biological samplesimultaneously with an organ or tissue is desired.

SUMMARY

A perfusion device for transport, assessment, treatment and/or storageof an organ or tissue as described herein may be configured to carry oneor more biological samples in addition to the organ or tissue. Such adevice may reduce cost, conserve space, provide convenience, and/orincrease security to the organ or tissue and the biological sample(s).The device may conveniently carry various biological samples of varioussizes with the organ or tissue. Documents for each of the biologicalsample(s) and the organ or tissue may stay together in the same deviceto ensure that they are readily accessible and continuously associatedwith one another, which may readily allow confirmation that the organ ortissue and the biological sample(s) are suitable for use such astransplantation and/or testing. The device may efficiently and compactlymeet sterility, viability and temperature requirements for the organ ortissue as well as the biological sample(s).

Exemplary implementations according to this disclosure may include anapparatus for at least one of storage, assessment, treatment andtransport of an organ or tissue. The apparatus includes a coolantcontainer configured to cool and optionally support the organ or tissue,and a sample compartment for holding a biological sample separate fromthe organ or tissue, wherein the coolant container is configured to cooland optionally support the sample compartment. The coolant container mayinclude a first cavity and a second cavity, wherein the first cavity isconfigured to cool and optionally support the organ or tissue, and thesecond cavity is configured to cool and optionally support thebiological sample. The first cavity and the second cavity may beseparate from each other. The second cavity may define at least aportion of the sample compartment and/or be located in a corner of thecoolant container.

Exemplary implementations according to this disclosure include a firstinternal compartment under a first cover of the apparatus, the firstinternal compartment including the coolant container and the samplecompartment. The apparatus may include a second internal compartmentunder a second cover that is configured to close the apparatus incooperation with the first cover, wherein the sample compartment is notaccessible when the first cover is closed and the second cover is openor closed. The second internal compartment may include a second samplecompartment, a heat-generating device and/or at least part of aperfusion circuit. An interior wall of the first internal compartmentmay act in cooperation with the second cavity to define the samplecompartment. The sample compartment may be located in a corner of thefirst internal compartment located farthest away from the secondinternal compartment.

Exemplary implementations according to this disclosure include a samplecompartment that is configured to support a sample container (specimencup). The sample compartment may be shaped to complementarily supportthe specimen cup. The apparatus may include the sample compartment beingconfigured to support a first specimen cup with a first shape and thesecond sample compartment being configured to support a second specimencup with a second shape, wherein the first and second shapes aredifferent. The apparatus may include a cooling structure that providesexternal cooling air to cool the apparatus.

Exemplary implementations according to this disclosure include a kit inthe form of a saleable package containing a sterilized basin configuredto hold an organ or tissue in a perfusion apparatus, a sterilized cradleconfigured to support the organ or tissue in the sterilized basin, and asterilized specimen container.

Exemplary implementations according to this disclosure include a methodof storage, assessment, treatment and/or transport of an organ ortissue. The method includes transporting the organ or tissue in a basinsupported in the coolant container, and transporting a biologicalsample, which is associated with the organ or tissue, in a specimencontainer placed in the sample compartment. The method may includecooling both the organ or tissue and the biological sample to a sametemperature.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary implementations are described herein with reference to thefollowing figures wherein:

FIG. 1 illustrates a schematic diagram of an exemplary perfusionapparatus for an organ or tissue;

FIG. 2 illustrates a top view of an exemplary perfusion apparatus in anuncovered state;

FIG. 3 illustrates a first exemplary cross-sectional perspective view,taken along the line 3-3 in FIG. 2, of an internal compartment of theapparatus;

FIG. 4 illustrates an exemplary top view of the apparatus of FIG. 2 in acovered state;

FIG. 5 illustrates an exemplary perspective view of the coolantcontainer of FIG. 2;

FIG. 6 illustrates a second exemplary cross-sectional perspective view,taken along the line 6-6 in FIG. 2, of the apparatus; and

FIG. 7 illustrates an exemplary bottom perspective view of the apparatusof FIG. 2.

DETAILED DESCRIPTION OF EMBODIMENTS

The following exemplary embodiments refer to transport, storage,treatment and/or assessment apparatus for an organ or tissue and abiological sample. It should be appreciated that, although the exemplaryembodiments according to this disclosure may be applicable to specificapplications, the depictions and/or descriptions included in thisdisclosure are not intended to be limited to any specific application.Any perfusion apparatus and method that may advantageously involve anorgan or tissue and a biological sample as described in an exemplarymanner in this disclosure are contemplated.

Blood samples and tissue samples may be used in laboratory testing toconduct a variety of tests to obtain information about an organ ortissue, the donor and/or the recipient. For example, they may be used toidentify specific antigens. An antigen is any substance that causes theimmune system to produce antibodies against that substance. A tissuesample may be, for example, but not limited to, a tissue sample of adonor such as blood, lymph or a spleen. Tissue samples may be acquiredduring a biopsy to identify potential diseases in the organ or tissueprior to transplantation. Tissue samples may be used in laboratorytesting for tissue typing. Tissue typing is a test that determineswhether organ compatibility exists between the donor and a potentialrecipient of transplantation. Serology analyzes blood serum and otherbodily fluid and may be conducted with blood and/or other tissue samplesto determine allergic reactions in the organ or tissue recipient anddiagnose and/or treat other potential concerns prior to transplantationor other use of an organ or tissue. These tests may also help inpredicting or diagnosing medical problems immediately aftertransplantation. Thus, it may be advantageous to have tissue samplesreadily available prior to organ transplantation or other use for thesetesting purposes.

FIG. 1 is a schematic diagram of a perfusion apparatus 10 for an organ20. The organ 20 may preferably be a liver, kidney, heart, lung, orintestine, but may be any human or animal, natural or engineered,healthy, injured or diseased organ or tissue. As used herein, the term“organ” is used to mean organ and/or tissue unless otherwise specified.The apparatus includes a basin 30 in which the organ may be placed. Thebasin 30 may hold a cradle 60 as illustrated in FIG. 3, which preferablyincludes a surface on which the organ 20 is disposed when the organ 20is in the apparatus 10. The basin 30 may include a first filter that canfunction as a gross particulate filter. The basin 30 and/or the cradle60 are preferably configured to allow a perfusate bath to form aroundthe organ 20. The basin 30 and/or apparatus 10 may also include one ormore temperature sensors 40 located in or near the cradle 60. Theapparatus 10 and/or basin 30 may include one or more additionaltemperature sensors 40, which may provide redundancy in the event of afailure and/or may provide temperature measurement at multiplelocations. Preferably, the temperature sensor(s) 40 is an infraredtemperature sensor. The temperature sensor(s) 40 is preferably disposedas close as practical to the organ 20 when the organ 20 is disposed inthe cradle 60 in order to improve the usefulness and accuracy of thetemperature sensor(s) 40, which preferably provide a temperaturemeasurement of the perfusate that may be correlated to a temperature ofthe organ 20. Alternatively or additionally, the temperature sensor(s)40 may be used to directly measure the temperature of the organ 20.

The basin 30 is preferably disposed within a recess of a coolantcontainer 50 that may contain cold materials such as ice, ice water,brine or the like. Coolant container 50 may be permanently or removablyattached to, or an integral, monolithic part of, apparatus 10. Thus, inuse, the organ 20 is disposed within the cradle 60, which is disposedwithin the basin 30, which is disposed within a recess of the coolantcontainer 50. Preferably, each of the basin 30, cradle 60 and coolantcontainer 50 is configured, or keyed, to fit within its correspondingmating component in a single orientation in use. The configuration ofthe coolant container 50, basin 30 and cradle 60 may provide aconfiguration that provides cooling for the organ 20 without thecontents of coolant container 50 contacting the organ 20 or the cradle60. Although the coolant container 50 is described herein as containingice, any suitable cooling medium can be used. Ice may be preferable dueto the ease with which ice can be procured, but one of ordinary skillwould understand that any suitable cooling medium, which could be anactive cooling medium (such as a thermo electric cooler or a refrigerantloop) or a passive cooling medium similar to ice or ice water, or acombination thereof, may be utilized. The amount of ice, or othercooling medium, that can be placed within the coolant container 50should be determined based upon the maximum time that cooling is to beprovided while the organ 20 will be in the apparatus 10.

The cradle 60 may include components configured to securely restrain theorgan 20 in place. Such components may, for example, include userselectable netting that is fastened to the cradle 60.

After passing through the filter 32, the perfusate flows along a firstflow path 70 that includes a suitable fluid conduit 72, such as flexibleor rigid tubing, a pump 80, a pressure sensor 90, a second filter 34, anoptional oxygenator 100 and a bubble trap 110, each of which isdiscussed below.

The first filter 32 is preferably a relatively coarse filter (relativeto the second filter 34). Such a coarse filter may be provided toprevent large particles, which may for example be byproducts of theorgan or of the organ being removed from the donor, from entering andclogging fluid paths of the apparatus 10. The first filter 32 may be anintegral part of the basin 30 or the first filter may be disposedelsewhere in the first flow path 70 downstream of the basin 30. Thefirst filter 32 may also be a separate component from the basin 30 ordisposed within the fluid conduit 72.

The first flow path 70 may also include a pump 80. The pump 80 may beany pump that is suitable in connection with perfusing of organs.Examples of suitable pumps may include hand-operated pumps, centrifugalpumps and roller pumps. If a roller pump is included, the roller pumpmay include a single channel or flow path (where only one tube iscompressed by the rollers) or the roller pump may include multiple,parallel channels or flow paths (where multiple tubes are compressed bythe rollers). If multiple, parallel channels or flow paths are included,the rollers may preferably be disposed out of phase or offset so thatpulses created by the rollers are out of phase, which may result in afluid flow out of the roller pump that is relatively less pulsatile thanwould be the case with a single roller. Such a multiple channel rollerpump may achieve a constant flow rate or a minimally pulsatile flowrate, which may be advantageous depending on the other components in theflow path and/or the type of organ being perfused.

The flow path 70 may include a pressure sensor 90. The pressure sensor90 may be preferably disposed after the outlet of the pump 80 in orderto monitor and/or be used to control the pressure produced at the outletof the pump by way of a suitable controller. The pressure sensor 90 mayprovide continuous or periodic monitoring of pressure.

The flow path 70 may include an oxygenator 100 such as an oxygenatormembrane or body to provide oxygenation to the perfusate. Oxygen may beprovided to the oxygenator 100 by any suitable means. Suitable oxygensources may include pure oxygen or mixed gases such as air. The gas maybe compressed, such as in a high-pressure cylinder, liquefied as wouldbe stored in a dewar, or drawn from the surrounding atmosphere.Preferably, the oxygen may be provided by way of an oxygen generator,which may be separate from the apparatus 10 or integral to the apparatus10. Oxygen may be generated through any suitable means, some examples ofwhich include through pressure swing adsorption using a molecular sieve,through a ceramic oxygen generator (a solid state oxygen pump) orthrough decomposition of water.

The flow path 70 may include a bubble trap 110. The bubble trap 110preferably separates gas bubbles that may be entrained in the perfusateflow and prevents such bubbles from continuing downstream and enteringthe organ 20. The bubble trap 110 may also function as an accumulatorthat reduces or eliminates pulsatility of the perfusate flow. The bubbletrap 110 may include a volume of gas, initially or through theaccumulation of bubbles, such that pressure fluctuations in theperfusate are dampened or eliminated.

The bubble trap 110 may include a vent that allows purging of gas duringstart up or a purging process. The vent may be connected to or part ofpurge flow path 140. The vent is preferably open during a start upprocess so that any air or other gas may be purged from the perfusatepath 70. When the vent is open, valves 122, 132 will preferably both beclosed. Once the gas is purged from the perfusate path 70, the vent maypreferably be closed. The vent may be closed manually or may be closedautomatically by way of a suitable controller.

The bubble trap 110 may include a level sensor 112. A level sensor 112may optionally be used during the purging process to determine when thepurging is complete and/or may be used to determine when the purgingprocess needs to be repeated, which may happen after gas has beentrapped in the bubble trap 110. Also, through use of the level sensor112 and the vent, the accumulator function of the bubble trap can betuned to account for differing amplitudes and frequencies of pulsatilityin the perfusate flow. The accumulator function of the bubble trap maybe tuned, for example, by adjusting the volumetric ratio of air toperfusate fluid.

The bubble trap 110 may have any number of outlets, as needed for agiven application of the perfusion apparatus 10. In FIG. 1, threeoutlets are shown connected to three different flow paths, which may beparticularly suited for the perfusion of a liver. When perfusing aliver, the three paths preferably include portal flow path 120 connectedto the portal vein of a liver, hepatic flow path 130 connected to thehepatic artery of a liver, and bypass flow path 140 that provides areturn path to the basin 30. There may also be a port in any fluid paththat allows fluid access to the perfusate solution. The port maypreferably be located in the bubble trap 110. This port may preferablyinclude a luer type fitting such that a user may extract a small asample of the perfusate for analysis. The port may also be utilized by auser to add substances such as drugs to the perfusate without openingthe basin.

As shown in FIG. 1, the portal flow path 120 and hepatic flow path 130may optionally include similar or different components such as valves122, 132; bubble sensors 124, 134; flow sensors 126, 136; flow controlclamps 127, 137; and pressure sensors 128, 138. Each similar componentmay function in a similar manner, and such pairs of components mayoptionally be structurally and/or functionally identical to reducemanufacturing costs. Flow sensors 126, 136 may preferably be ultrasonicsensors disposed around tubing, although any suitable sensor may beused. Ultrasonic sensors may be advantageous because in normal usagesuch sensors do not come into contact with the perfusate and thereforeare not in the sterile path. Such an implementation of ultrasonicsensors does not require replacement and/or cleaning after use.

Valves 122, 132 may be pinch valves that function to squeeze tubing andreduce or shut off flow, but any suitable valve may be used. Pinchvalves may be advantageous because in normal usage they do not come intocontact with the perfusate and therefore do not require replacementand/or cleaning after use.

Preferably, the bubble sensors 124, 134 are ultrasonic sensors disposedaround tubing, although any suitable sensor may be used. Similar topinch valves, ultrasonic sensors may be advantageous because in normalusage they do not come into contact with the perfusate and therefore donot require replacement and/or cleaning after use. Instead, ultrasonicsensors can be disposed in contact with, adjacent to or around anexternal surface of tubing in order to sense bubbles.

Flow control clamps 127, 137 may be used to fine-tune the flow rate inone or both of portal flow path 120 and hepatic flow path 130.Preferably, the organ provides self-regulation to control flow thatexits the bubble trap 110 and is divided between the portal flow path120 and the hepatic flow path 130. In such self-regulated flow, pressuresensors 128, 138 provide overpressure monitoring. In the event thatpressure delivered to the organ in either or both of the portal flowpath 120 or the hepatic flow path 130 exceeds a predetermined threshold,the apparatus 10 can automatically stop and/or reduce the flow rateprovided by the pump 80 to prevent damage to the organ. In addition oralternatively, the pressure sensors 128, 138 may be used to generatewarning signals to the user and/or to an appropriate controller aspressures approach the predetermined threshold. An alternate softwarealgorithm may be employed to allow the apparatus 10 to perfuse at apreferred pressure. For example, a software algorithm may allow a doctoror clinician to select a specific pressure and vary the flow rateaccordingly.

After exiting one or both of the portal flow path 120 and hepatic flowpath 130, perfusate flows through the organ and returns to the basin 30to form an organ bath.

Bypass flow path 140 may include a valve 142, and/or sensors such asoxygen sensor 144 and pH sensor 146. Preferably, the valve 142 is apinch valve and may be of similar configuration to valves 122 and 132,but any suitable valve may be used. The oxygen sensor 144 and the pHsensor 146 may be used to determine the state of the perfusate.Preferably, the bypass flow path 140 is only used during a purging orpriming process, although it may also be used during perfusion,preferably continuously, to monitor perfusate properties in real time.

The organ perfusion apparatus 10 may also include an accelerometer 150.Preferably the accelerometer 150 is a three-axis accelerometer, althoughmultiple single axis accelerometers may be used to the same effect. Theaccelerometer 150 may be used to continuously or periodically monitorand/or record the state of the apparatus 10. Monitoring may includemonitoring for excessive shocks as well as attitude of the apparatus 10.For example, if a pitch or a roll exceeds a pre-set alarm limit, theaction of the pump 80 may be momentarily interrupted to stop the flow ofperfusate until that specific condition is corrected. By implementingsuch monitoring, misuse or potentially inappropriate conditions of theapparatus 10 can be detected and recorded and appropriate action can betaken.

Preferably, all components of the apparatus 10 that come into contactwith perfusate and/or an organ and/or a biological sample are disposableand/or easily replaced. Such disposable items may be included in a kitor saleable package. For example, such a kit may include packaging suchas plastic or shrink wrap packaging containing some or all of thecomponents that come into contact with an organ, biological sample,and/or perfusate. In embodiments, the tubing, filter, oxygenator andbubble trap may be packaged together in a manner preconfigured to beplaced into the apparatus 10. The cradle and basin may be packagedindividually or together, and optionally together with the tubing,filter, oxygenator and bubble trap, and specimen cups may be packagedwith or separate from such other components.

Specimen cup(s) 170D, basin 30, cradle 60 and other components may beincluded in a disposable kit and may be sterilized prior to use. Forexample, the specimen cup(s) 170D may be wrapped in a separate baghaving a closed environment to maintain sterility prior to storing abiological sample and placing the specimen cup(s) 170D in the apparatus10. In this manner, contamination to the tissue or organ and biologicalsamples can be minimized. The specimen cup(s) 170D may be a disposableitem, optionally packaged in a sterile kit with other disposablecomponents of the perfusion apparatus 10 such as the basin, and/orcradle, and/or other components, and discarded after use.

The apparatus 10 may include storage compartments for items other thanthe organ 20. For example, the apparatus 10 may include a documentcompartment 160 (FIG. 3) to store documents and/or charts related to theorgan 20. Also, the apparatus 10 may include one or more samplecompartment(s) 170(A-C). The sample compartment(s) 170(A-C) may beconfigured, for example, to store liquid and/or solid tissue samples.The sample compartment(s) 170(A-C) may be advantageously disposed near,or separated from, the coolant container 50 to provide cooling that maybe the same, similar to, or different from the cooling provided for theorgan 20.

FIG. 2 illustrates a top view of an exemplary apparatus 10 when thecover 200 and second cover 220 are removed. A plurality of samplecompartment(s) 170(A-C) may be advantageously disposed at variouslocations in the apparatus 10. The sample compartment(s) 170(A-C) maycarry different types of biological samples (not shown), which mayinclude, but are not limited to, vasculature and blood samples.

A container such as a sealable specimen cup 170D may be placed withinthe sample compartment(s) 170(A-C) to advantageously accompany the organ20 during perfusion, transport, and/or storage of the organ 20. Thesample compartment(s) 170(A-C) may be configured to secure and supportvarious sizes and shapes of the specimen cup. For example, the specimencups 170D may include, but are not limited to, blood tubes, plastictissue sample containers and plastic urinalysis cups. The specimen cups170D may vary in size. Different biological samples such as blood,tissues and organ vasculature may be carried by various types ofspecimen cups 170D. For example, blood tubes are generally between 5-10cm.sup.3 in size. A standard urinalysis cup is a type of specimen cup170D that may be used to carry liver blood vessels. Conical tubes arecommonly used for spleen and lymph nodes. They are generally between5-20 cm.sup.3 in size.

The specimen cup(s) may preferably be used to hold biological samplessuch as donor vasculature. Donor vasculature may be used to rebuildvasculature, such as a vein or an artery, cooperating with the organ 20in the body of the recipient during organ transplantation. Rebuilding ofvasculature may be necessary in situations where the vasculature of theorgan recipient may be damaged and/or not functional before, during orafter organ transplantation. It may be advantageous to carry donorvasculature with the organ 20 for co-storage and/or transport ofvasculature or other biological specimens. Carrying donor vasculaturewith the organ 20 may provide the advantage of facilitating rebuildingthe vasculature of the organ recipient with the donor vasculature sothat the compatibility of the vasculature to the organ 20 may bemaintained. By maintaining the compatibility of the vasculature to theorgan 20, the likelihood that the recipient's body may reject the donororgan 20 may be minimized. Additionally, proper functionality of theorgan 20 within the recipient's body may be improved.

Sample compartment(s) 170(A-C) may be located in internal compartments300, 310 of the apparatus 10. A compartment, for example the firstinternal compartment 300, may be a section of the apparatus 10 that isdefined by a plurality of walls or regions that divide the apparatus 10.A compartment may be structurally divided within the apparatus 10 orfunctionally divided by the relative location of components of theapparatus 10. Compartments may be defined as specific enclosures for agroup of elements that function in relation to one another. Compartmentsmay also be defined with respect to the position of correspondingcovers. For example, FIG. 4 illustrates that components under thesecovers may be defined as being in different compartments. First internalcompartment 300 may be defined to be under cover (lid) 200 and a secondinternal compartment 310 may be defined to be under the second cover(lid) 220. The first internal compartment 300 may include the basin 30,part or all of the coolant container 50 and/or the cradle 60. The secondinternal compartment 310 may include the pump 80, the bubble trap 110,the second filter 34, valves 122, 132, bubble sensors 124, 134 and/orflow sensors 126, 136.

As can be particularly appreciated from FIG. 1, an overall container fororgan perfusion apparatus 10 may hold numerous components in a smallvolume. Thus, volume for biological samples and/or documents ispreferably reserved and allocated in specific, efficient ways inembodiments described herein.

Preferably, a specimen cup 170D may be located in a sample compartment170(A), the first sample compartment, adjacent to where the cradle 60and organ 20 may be placed. It may be advantageous to place the specimencup 170D carrying donor vasculature, for example, near the organ 20 ifthe organ 20 and donor vasculature require low temperatures forpreservation. Thus, it may be helpful to place biological samples havingsimilar viability requirements as the organ 20 near the organ 20. On theother hand, biological samples such as blood, for example, may notrequire such low temperatures and therefore may not need the same levelof temperature control. Accordingly, sample containers such as bloodtubes, for example, may be located at other positions in the apparatusaway from the organ 20.

The coolant container 50 may have one or more cavities or recesses inwhich the specimen cup 170D and/or basin 30 may be placed. The basin 30and the specimen cup 170D may be placed in the same cavity or inseparate cavities of the coolant container 50. Bottom and sides of thebasin 30 and/or the specimen cup 170D may be completely enclosed by thecavity. Alternatively, the basin 30 and/or the specimen cup 170D may beat least partially enclosed by the cavity. For example, a portion of aside surface of the specimen cup 170D may not be surrounded by thecavity of the coolant container 50. The coolant container 50 may have aplurality of sample compartments 170A to support multiple specimen cups170D depending on the size and shape of the organ/tissue receivingcavity.

FIG. 5 illustrates a coolant container 50 with a first cavity 400 wherethe basin 30 may be placed and a cavity defining sample compartment 170Awhere one or more specimen cup 170D may be placed. The walls of thefirst cavity 400 may surround the basin 30 on its bottom and sides. Forexample, the first cavity 400 may have a bottom wall that supports thebasin 30. The specimen cup 170D may be partially surrounded by walls ofthe coolant container 50 in the sample compartment 170A, as illustratedin FIGS. 2 and 5. The walls of the sample compartment 170A may include asidewall and a bottom wall. Preferably, the sidewall of the samplecompartment 170A may be located at a corner of the coolant container 50.Internal walls of the first internal compartment 300 in combination withthe walls of the coolant container 50 may provide support for and/orrestrain the specimen cup 170D in the apparatus 10. Alternatively,multiple sidewalls of sample compartment 170A may be defined by surfacesof the coolant container 50. The amount of surface area of the coolantcontainer 50 may be selected to achieve a desired temperature range forthe biological sample(s).

It may be advantageous to place basin 30 and specimen cup 170D incavities in the coolant container 50 so that the organ 20 and thebiological sample are cooled in a similar manner. Placing the basin 30and the specimen cup 170D in separate cavities of the coolant container50 may provide a similar degree of cooling to the organ 20 and thebiological sample. Additionally, having separate cavities in the coolantcontainer 50 allows the specimen cup 170D to be positioned apart fromthe organ 20, basin 30 and/or cradle 60 so that the specimen cup 170Ddoes not act as an obstacle or contamination source during the handlingof the organ 20, basin 30 and/or cradle 60 in the apparatus 10. It mayalso be advantageous for the specimen cup 170D and basin 30 to be inthermal contact with multiple surfaces of the coolant container 50 tomaximize cooling efficiency. The amount of thermal contact between thecoolant container 50 and the specimen cup 170D and/or basin 30 may beoptimized to achieve a desired temperature range.

The first internal compartment 300 may include a cavity to support thecoolant container 50 and/or the specimen cup(s) 170D. The cavity of thefirst internal compartment 300 may be at various positions in theapparatus 10 depending on the size and shape of the organ 20, basin 30and/or cradle 60. For example, the first internal compartment 300 mayhave a cavity in which basin 30, most of coolant container 50, and/orcradle 60 are located, as illustrated in FIG. 2. The walls of the firstinternal compartment 300 may be configured to surround at least aportion of a side of specimen cup 170D. Preferably, the basin 30 andspecimen cup 170D may be positioned to be in contact with walls of thecoolant container 50 and/or walls of the first internal compartment 300so that temperatures established by the cooling medium can be moreeffectively regulated. This configuration advantageously allows forseparate temperature regulation of the basin 30 and the specimen cup170D. Energy from heat-generating components of the second internalcompartment 310 may be used to control the temperature of the biologicalsamples in specimen cups 170D via at least heat transfer from the secondinternal compartment 310. On the other hand, the temperature of theorgan 20 in the basin 30 may be more isolated and directly controlled bythe coolant container 50. Various configurations of the cradle 60, basin30, sample compartment(s) 170(A-C) and coolant container 50 may becontemplated to achieve the desired temperature regulation.

FIGS. 2 and 5 illustrate that a sample compartment 170A may bepositioned in a corner of the first internal compartment 300 that isrelatively far from the second internal compartment 310. The position ofthe sample compartment 170A may be dependent upon the shape and size ofthe coolant container 50 and/or basin 30 to maintain a compactconfiguration in the first internal compartment 300 and/or apparatus 10.Preferably, the sample compartment 170A may be located at a positiondistant from the second internal compartment 310, and may be defined atleast in part by an internal surface of the first internal compartment300 that is physically separated from the second internal compartment310. For example, the cradle 60 and/or basin 30 may be located betweenthe sample compartment 170A and the second internal compartment 310.Most of the heat and/or vibration generated during the operation of theapparatus 10 is produced by components in the second internalcompartment 310. Thus, it may be advantageous to locate the samplecompartment 170A as far away as practical from the second internalcompartment 310 to more effectively and more efficiently maintain thetemperature of the specimen cup 170D in the sample compartment 170A andto provide a more stable environment. Alternatively, it may beadvantageous to locate sample compartment(s) 170A at various positionsin the first internal compartment 300 depending on the desiredtemperature. For example, a specimen cup 170D may be positioned closerto the second internal compartment 310 where heat generating componentsare located if a higher temperature is desired for a biological sample.Thus, placement of the sample compartment(s) 170A can take advantage ofheating and/or cooling throughout the apparatus 10. Multiple samplecompartments 170A may be contemplated at various locations in the firstinternal compartment 300.

As discussed above, the coolant container 50 may contain a coolingmedium (such as ice, ice water or brine, not shown) used to cool theorgan 20. If a sample compartment 170(A-C) is disposed near the coolantcontainer 50, the coolant container 50 may also advantageously cool thesample compartment 170(A-C) and thus the contents of a specimen cup170D. The sample compartment(s) 170A may be located at least partiallywithin a cavity of the coolant container 50 and/or in contact with thecoolant container 50 to cool the contents of the coolant compartments(s)170A with the same cooling medium as the organ 20. This configurationmay regulate the temperature of a biological sample in specimen cup 170Dand the organ 20 such that these temperatures are as close as practical.The coolant container 50 may at least partially surround the basin 30and/or the sample compartment(s) 170A. It may be advantageous not tosurround a portion of the basin 30 and/or sample compartment 170A, forexample, for ease of handling and access.

A portion of the coolant container 50 may extend into the secondinternal compartment 310, or within the area under the second cover 220.This portion may include an opening that allows the coolant container 50to be filled with the cooling medium. The opening of this portion of thecoolant container 50 may include a cap with a locking mechanism and/or asealing mechanism to ensure that the cooling medium is fully enclosedwithin the coolant container 50 and to provide a leak free arrangement.This configuration advantageously allows the cooling medium to be addedor changed without opening the cover 200 of the first internalcompartment 300.

Preferably, the cooling medium may maintain a temperature between1.degree. C. and 15.degree. C. in the sample compartment(s) 170A and thebasin 30. More preferably, the cooling medium may maintain a temperaturebetween 5.degree. C. and 10.degree. C. in the sample compartment(s) 170Aand the basin 30. For example, the cooling medium may maintain atemperature between 6.degree. C. and 8.degree. C. in the samplecompartment 170A and the basin 30. Preferably, the temperature may bemaintained for a period of time greater than 25 hours. More preferably,the temperature may be maintained for a period of time greater than 30hours. For example, the temperature may be maintained between 6.degree.C. and 8.degree. C. for a period of time greater than 35 hours atstandard temperature and pressure (STP). Positioning the coolantcontainer 50 with the cooling medium, the basin 30 and/or the samplecompartment(s) 170(A-C) in relationship with one another provides theadvantage of cooling the biological sample and the organ 20simultaneously and efficiently by the same cooling system. This may beespecially helpful for certain biological samples where requirementssuch as viability, temperature and compatibility are present.Additionally, the biological samples and the organ 20 may be monitoredand examined in the same proximate area of the apparatus 10.

The apparatus 10 may include a motor 320 for the pump 80. The apparatus10 may include a cooling structure 420 that is configured to provideexternal cooling air to cool the motor 320 and draw away heat from theinterior of the apparatus 10, as illustrated in FIGS. 6 and 7. Thecooling structure 420 may include a fan that is configured to drawoutside air into the apparatus 10 and/or exhaust internal air from theapparatus 10. FIG. 7 illustrates that the cooling structure may includeinlet and outlet vents to cycle air into and/or out of the apparatus 10.It may be advantageous to position the fan and/or the vents at hightemperature areas of the apparatus 10 to efficiently remove unwantedheat. Components of the apparatus 10 that produce heat may define thelocations of the high temperature areas. These components of theapparatus 10 may include, but are not limited to, the motor, powersupply and transformer, batteries, pump 80, a display screen and otherelectronics. Vents may be positioned at various locations of theapparatus 10 to prevent overheating of components, maximize airflowthroughout the apparatus 10, and achieve temperature regulation ofvarious sample compartment(s) 170(A-C). External cooling air mayadvantageously provide improved thermal efficiency of the apparatus 10during operation of the motor.

A plurality of biological samples may also or alternatively be carriedin sample compartments 170B and/or 170C. Specimen cups may be placedwithin separate sample compartments 170B and/or 170C of the apparatus 10to accompany the organ 20 during perfusion, transport, treatment and/orstorage of the organ 20. The sample compartments 170B and/or 170C may belocated in the second internal compartment 310 of the apparatus 10.Preferably, the sample compartments 170B and/or 170C may be located inthe second internal compartment 310 of the apparatus 10 where heatgenerating components may be located. For example, sample compartments170E and/or 170C may be located adjacent to the pump 80 and may also belocated adjacent to each other. Preferably, sample compartments 170Band/or 170C are used with biological samples that require less stricttemperature control and/or warmer temperatures than provided for thebasin 30 and sample compartment(s) 170A.

The sample compartments 170B, 170C may be positioned at variouslocations depending on the locations of the components of the perfusioncircuit 330 to optimize space constraints, to take advantage of the flowof air in the apparatus 10, to achieve the desired temperature range foreach of the biological samples, and/or to maintain a compactconfiguration.

The combination of at least the cooling structure 420, the position ofthe coolant container 50, the location of the heat generatingcomponents, the position of open spaces around the respective heatgenerating components, and the flow path where the air in the apparatus10 flows may minimize the effects of heat produced by the heatgenerating components and aid in maintaining an appropriate temperaturelevel for the sample compartments 170B, 170C. Although these samplecompartments are not located in the first internal compartment 300, thetemperature of biological samples in them can be effectively regulatedin the second internal compartment 310.

The sample compartments 170B and/or 170C may be cooled by the coolingmedium in the coolant container 50, as illustrated in FIG. 2, eventhough they are not bounded by the coolant container 50. Thisconfiguration may be advantageous because some biological samples mayhave less stringent temperature or viability requirements, or mayrequire warmer temperatures, than other biological samples. As a result,space optimization and compactness of the apparatus 10 is achieved whileproviding temperature regulation of the sample compartments 170B and/or170C. Various types of biological samples may be advantageously placedrelatively distant from the organ 20 and/or coolant container 50, yetwithin the apparatus 10, to satisfy space constraints and conveniencewhile maintaining security and/or cooling requirements of the organ 20and/or biological samples.

The location of sample compartments 170B, 170C under the second cover220 in the second internal compartment 310, as illustrated in FIG. 4,allows the biological samples to be accessed only from the interior ofthe apparatus 10. Moreover, the biological samples may be accessiblewithout opening the cover 200 of the first internal compartment 300where the organ 20 may be located. This configuration may advantageouslyprotect the organ 20 from unauthorized access, minimize coolingdisruptions, and/or maintain the sterile environment. Additionally,having two separate internal compartments 300, 310 and two respectivecovers 200, 220 may provide more effective temperature regulation of theorgan 20 and biological samples within the apparatus 10.

Preferably, the sample compartment(s) 170(A-C) may be configured to actas holders to secure and support the specimen cup(s) 170D. Close fittedsample compartments may hold the specimen cup(s) 170D. The samplecompartments 170A, 170B and/or 170C may be of the same or differentshapes. Thus, the sample compartments 170(A-C) in the apparatus 10 maycarry various shapes and sizes of biological samples. The samplecompartments 170(A-C) of the apparatus 10 need not be constructed forspecific shapes and sizes. Handling fixtures, for example, may accompanythe specimen cups) to secure them in the sample compartments 170(A-C) ofthe apparatus 10. Such handling fixtures may also be provided in a kitwith specimen cup(s) and/or other components. This configuration mayadvantageously provide a versatile apparatus 10 to carry biologicalsamples of various shapes and sizes. The specimen cup(s) 170D may be forsingle use and therefore disposable. The sample compartments 170(A-C)may be configured to secure and support different sizes and shapes ofspecimen cup(s) 170D. The sample compartments 170(A-C) may be insulatedto protect the specimen cups) 170D from damage. Insulation may alsoprotect the specimen cup(s) 170D during turbulent transport of theapparatus 10.

It may be advantageous that documents are safely stored and kepttogether with an organ. If the documents for the organ are lost ordisassociated with the organ, then a doctor or clinician may refuse totransplant the organ and/or otherwise use the organ. This is because thetransplantation or other use may require data to ensure, for example,compatibility of the organ to a recipient, chain of custody to ensurethat the organ has not been tampered with during transport, identity ofthe organ to confirm that the organ is the organ requested fortransplant or other use, and/or viability of the organ to ensure thatthe organ is stable and prepared for transplantation or other use. Ifdocuments for the biological samples are lost or cannot be correlated tothe organ and samples being transplanted, the results from any testingof the biological samples may not be used or useful because the originalstate of the biological samples and their relationship to the organ isuncertain.

The apparatus 10 may carry associated documents, such as donor medicalrecords and/or organ data, in the document compartment 160. The documentcompartment 160 may be positioned between the cover 200 and lid 210 inthe first internal compartment 300, or in the second internalcompartment 310. Preferably, the cover 200 and the lid 210 form thedocument compartment 160. FIG. 3 illustrates a portion of the documentcompartment 160 formed on the lid 210. Wall portions 230 may protrudefrom a top surface of the lid 210. The wall portions 230 may be integralto the lid 210 or they may be separate parts that are connected to thelid 210 during assembly. The wall portions 230 may act as side surfacesof the document compartment 160 and the top surface of the lid 210 mayform the bottom internal surface of the document compartment 160. Whenthe first internal compartment cover 200 closes the first internalcompartment 300, the document compartment 160 may be closed. As aresult, the bottom surface of the first cover 200 may be the topinternal surface of the document compartment 160 and the top surface ofthe lid 210 may be the bottom internal surface of the documentcompartment 160. Alternatively, or in addition, lids of the compartment310 may have such a structure.

It should be appreciated that various features disclosed above and otherfeatures and functions, or alternatives thereof, may be desirablycombined into many other devices. Also, various alternatives,modifications, variations or improvements therein may be subsequentlymade by those skilled in the art, which are also intended to beencompassed by this disclosure.

1. An apparatus for at least one of storage, treatment, assessment andtransport of an organ or tissue, the apparatus comprising: a firstinternal compartment including a coolant container and a first samplecompartment, the coolant container having a cooling surface configuredto cool the organ or tissue, and the first sample compartment configuredfor holding a biological sample separate from the organ or tissue; adocument compartment configured to store documents separate from theorgan or tissue; and a first cover such that the first internalcompartment, coolant container, and document compartment are disposedunder the first cover.
 2. The apparatus of claim 1, further comprising asecond internal compartment and a second cover such that the secondinternal compartment is disposed under the second cover.
 3. Theapparatus of claim 2, wherein the second internal compartment includesat least one heat-generating device and a second sample compartment, thesecond sample compartment being configured for holding a biologicalsample separate from the organ or tissue.
 4. The apparatus of claim 2,wherein the first sample compartment is not accessible when the firstcover is closed regardless if the second cover is open or closed.
 5. Theapparatus of claim 2, wherein the second sample compartment is notaccessible when the second cover is closed, regardless if the firstcover is open or closed.
 6. The apparatus of claim 3, wherein the firstinternal compartment includes a third sample compartment, the thirdsample compartment being located closer to the heat-generating devicethan the first sample compartment.
 7. The apparatus of claim 3, whereinthe heat-generating device is a pump.
 8. The apparatus of claim 3,wherein the second internal compartment further includes a coolingstructure that cools the second internal compartment.
 9. The apparatusof claim 1, wherein the coolant container includes a cavity such that awall of the cavity also forms a wall of the first sample compartment.10. The apparatus of claim 9, wherein the cavity of the coolantcontainer is configured to receive a basin for holding the organ ortissue.
 11. The apparatus of claim 1, wherein the document compartmentincludes wall portions that are perpendicular to the first cover. 12.The apparatus of claim 1, wherein the document compartment is locatedbetween the first cover and a lid of the first internal compartment. 13.A method of using the apparatus of claim 1, the method comprising:transporting an organ or tissue in a basin in contact with the coolingsurface; and simultaneously transporting a biological sample, which isassociated with the organ or tissue, in a specimen container in thefirst sample compartment.